NCT01210976

Brief Summary

Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center. Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

September 24, 2010

Last Update Submit

September 20, 2011

Conditions

Heart Valve Disease

Keywords

levosimendanCABGAVR

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    up to 5 days

Secondary Outcomes (1)

  • echocardiography

    baseline, 1st and 5th postoperative day

Study Arms (2)

levosimendan

EXPERIMENTAL
Drug: levosimendan

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

levosimendanDRUG

12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min

levosimendan
placeboDRUG

nacl 0.9% coloured with thiamin in same volume and time than levosimendan

placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm

You may not qualify if:

  • allergy to levosimendan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

  • Leppikangas H, Jarvela K, Sisto T, Maaranen P, Virtanen M, Lehto P, Karlsson S, Koobi T, Lindgren L. Preoperative levosimendan infusion in combined aortic valve and coronary bypass surgery. Br J Anaesth. 2011 Mar;106(3):298-304. doi: 10.1093/bja/aeq402. Epub 2011 Jan 21.

    PMID: 21258075DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Heli Leppikangas, MD

    Department of Anaesthesia, Tampere UH

    PRINCIPAL INVESTIGATOR

  • Kati Järvelä, MD,PhD

    Heart Center, Pirkanmaa Hospital District

    STUDY CHAIR

  • Tero Sisto, MD, PhD

    Heart Center, Pirkanmaa Hospital District

    STUDY CHAIR

  • Pasi Maaranen, MD

    Heart Center, Pirkanmaa Hospitla District

    STUDY CHAIR

  • Pasi Lehto, MD,PhD

    Heart Center, Pirkanmaa Hospital District

    STUDY CHAIR

  • Marko Virtanen, MD,PhD

    Heart Center, Pirkanmaa Hospital District

    STUDY CHAIR

  • Sari Karlsson, MD

    Department of Intensive Care, Tampere UH

    STUDY CHAIR

  • Esko Ruokonen, MD,PhD

    Department of Intensive Care, Kuopio UH

    STUDY CHAIR

  • Leena Lindgren, MD,PhD

    Department of Anaesthesia, Tampere UH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 29, 2010

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

FI(1)